Contraceptive Adherence and ContinuationNCT01990001
Randomized Trial of Provider-Assisted Versus Patient-Initiated Enrollment in the Bedsider.Org Online Contraceptive Reminder Tool
A study testing enrollment in online reminder system in people with Contraceptive Adherence and Continuation, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The broad objective of this research is to determine whether a quick, simple intervention will increase utilization of contraceptive reminders and adherence to short-term contraceptive regimens. Such an intervention could be implemented easily with no additional resources into a busy clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 29 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraceptive Adherence and Continuation
- What is being tested?
- enrollment in online reminder system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female, 18-29 years old
- Prescribed one of the following birth control:
- Oral contraceptive pills, vaginal ring, transdermal patch, or Depo Provera
- Able to provide consent
- Have regular access to a computer, Ipad, or a hand-held device such as a smartphone.
- Women must be able to read and speak English(Bedsider website in not translated into Spanish)
Who cannot join
- Male
- Over the age of 30 years old
- Non-English Speaking
- Limited or no access to computer, Ipad or hand-held device(smartphone)
Trial locations and contacts
1 site in 1 country.
United States1 site
MUSC Women's Health- Cannon
Charleston, South Carolina, 29425
About this study
The broad objective of this research is to determine whether a quick, simple intervention will increase utilization of contraceptive reminders and adherence to short-term contraceptive regimens. Such an intervention could be implemented easily with no additional resources into a busy clinical practice.
Read the detailed description
The specific aims of the study are to:
- Measure the difference in reminder utilization over three months between patients who are assisted with initiating the reminder system during their office visit versus those who are encouraged to self-initiate after the visit.
- Assess whether provider-assisted enrollment in the online reminder system improves adherence to a short-term contraceptive regimen compared to self- initiated enrollment after the visit.
- Conditions
- Contraceptive Adherence and Continuation
- Being tested
- enrollment in online reminder system
- Keywords
- contraception, adherence, medication reminder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enrollment in online reminder systemOther
Study personnel enrolled members in the online reminder system during their office visit.
| Study group | Role | What they receive |
|---|---|---|
| Office enrollment in the online contraceptive reminder system | Experimental | Members of this arm were enrolled in the reminder system during their visit. Receives: Other: enrollment in online reminder system |
| Control | No intervention | Members in the control group were not enrolled in the reminder system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients using the online reminder tool three months after enrollment
Measure the difference in reminder utilization over three months between patients who are assisted with initiating the reminder system during their office visit versus those who are encouraged to self-initiate after the visit. The primary outcome, which is proportion of reminder users, will be assessed three months after enrollment
Measured: 3 months
Secondary outcomes (1)
Assess whether provider-assisted enrollment in the online reminder system improves adherence to a short-term contraceptive regimen compared to self- initiated enrollment after the visit.
Assess whether provider-assisted enrollment in the online reminder system improves adherence to a short-term contraceptive regimen compared to self- initiated enrollment after the visit. This data will be collected three months after enrollment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startAug 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraceptive Adherence and ContinuationStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Obstetricians and Gynecologists
- Responsible party
- Principal investigator, Ashlyn H. Savage, MD, Medical University of South Carolina
- Investigators
- Ashlyn Savage, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990001
- Sponsor's protocol ID
- Besider
- Status last verified
- Nov 2013
- First submitted
- 11 Nov 2013
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Provider-Assisted Versus Patient-Initiated Enrollment in the Bedsider.Org Online Contraceptive Reminder Tool
- ClinicalTrials.gov ID
- NCT01990001
- Acronym / sponsor ID
- Besider
- Conditions
- Contraceptive Adherence and Continuation
- Keywords
- contraception, adherence, medication reminder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- American College of Obstetricians and Gynecologists
- Study start
- Aug 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 21 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The broad objective of this research is to determine whether a quick, simple intervention will increase utilization of contraceptive reminders and adherence to short-term contraceptive regimens. Such an intervention could be implemented easily with no additional resources into a busy clinical practice.
Detailed description
The specific aims of the study are to:
- Measure the difference in reminder utilization over three months between patients who are assisted with initiating the reminder system during their office visit versus those who are encouraged to self-initiate after the visit.
- Assess whether provider-assisted enrollment in the online reminder system improves adherence to a short-term contraceptive regimen compared to self- initiated enrollment after the visit.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Office enrollment in the online contraceptive reminder system | Experimental | Other: enrollment in online reminder systemMembers of this arm were enrolled in the reminder system during their visit. |
| Control | No intervention | –Members in the control group were not enrolled in the reminder system |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female, 18-29 years old
- Prescribed one of the following birth control:
- Oral contraceptive pills, vaginal ring, transdermal patch, or Depo Provera
- Able to provide consent
- Have regular access to a computer, Ipad, or a hand-held device such as a smartphone.
Key exclusion criteria (4 listed)
- Male
- Over the age of 30 years old
- Non-English Speaking
- Limited or no access to computer, Ipad or hand-held device(smartphone)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enrollment in online reminder systemStudy personnel enrolled members in the online reminder system during their office visit. | Other | Office enrollment in the online contraceptive reminder system |
Primary outcome
Proportion of patients using the online reminder tool three months after enrollment
Time frame: 3 months
Measure the difference in reminder utilization over three months between patients who are assisted with initiating the reminder system during their office visit versus those who are encouraged to self-initiate after the visit. The primary outcome, which is proportion of reminder users, will be assessed three months after enrollment
1 secondary outcome
Assess whether provider-assisted enrollment in the online reminder system improves adherence to a short-term contraceptive regimen compared to self- initiated enrollment after the visit.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashlyn Savage, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enrollment in online reminder system in people with Contraceptive Adherence and Continuation, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients using the online reminder tool three months after enrollment (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015.